MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER

Catalog Number	DSF2265
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As it is unclear which device caused the rupture, an additional gore® dryseal flex introducer sheath device is captured on this report: sn: (b)(6), udi: (b)(4), catalog: dsf2033.H.6.Investigation findings code c19: the device history records were reviewed to ensure that each manufacturing and inspection operation was performed and indicated the products met creganna medical specifications and procedures.The devices were discarded at the treating facility and were therefore not available for analysis.H.6.Investigation conclusions code d1102: according to the gore® dryseal flex introducer sheath instructions for use (ifu), adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.If vessel size is smaller than the nominal body od , major bleeding, vessel damage, or serious injury to the patient, including death, may result.Additionally, the ifu states: adverse events that may occur and / or require intervention include, but are not limited to vascular trauma (i.E., dissection, rupture, perforation, tear, etc.) and bleeding.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.The vessel diameter of the injury site was about 7 mm.Per ifu sizing guide for the dsf2265, the id diameter is 7.3mm and od diameter is 8.2mm.Per ifu sizing guide for the dsf2033, the id diameter is 6.7mm and od diameter is 7.5mm.If vessel size is smaller than the nominal body od, major bleeding, vessel damage, or serious injury to the patient, including death, may result.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
The following was reported to gore: on (b)(6) 2023, prior to performing a transcatheter aortic valve implantation(tavi), the physician began endovascular treatment of a mural thrombus in a pre-existing non-gore stent graft.Gore® dryseal flex introducer sheaths (dsf) were used for access for the tevar.First, a 22fr dsf was inserted into the left common femoral artery.However, the physician felt resistance, and could not advance the sheath.The device was replaced with a 20fr dsf, but it could not be advanced either.A vessel rupture was then observed on the angiography.To treat the rupture, two stent grafts were placed from the left common iliac artery down to the left external iliac artery; however, it was confirmed that the rupture site was located more distal than the distal stent graft.The physician then elected to perform tavi without performing tevar.After the tavi was completed, the rupture site was treated surgically.The patient tolerated the procedure.Reportedly, there was a calcification in the distal part of left external iliac artery, and the diameter of the distal end of the external iliac artery was approximately 7mm.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, and h6: conclusion code d12.According to the gore® dryseal flex introducer sheath instructions for use (ifu), the user should stop advancement of the assembly if there is resistance.Investigate the cause of resistance before proceeding.Major bleeding, vessel damage, or serious injury to the patient, including death, may result.Corrected h6: conclusion code to d1101: failure to follow instructions from d1102 unintended use error caused or contributed to event.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17766019
• Report Number: 3007284313-2023-02762
• Device Sequence Number: 6617863
• Product Code: DYB
• UDI-Device Identifier: 00733132628384
• UDI-Public: 00733132628384
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2025
• Device Catalogue Number: DSF2265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Female